A Phase 1b Study With Volociximab in Combination With Carboplatin, Paclitaxel, and Bevacizumab in First-line, Advanced Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Abbott
Study ID
NCT00666692
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • M200 (Volociximab), Carboplatin, Paclitaxel, Bevacizumab — DRUG
    Volociximab will be administered via IV infusion once every three week at 10, 20, and 15 or 30 mg/kg with an additional loading dose in the 10, 20, and 15 mg/kg dose levels on Day 8 of the first cycle. Volociximab will be given for up to 6 cycles (3 weeks/cycle). Subjects who have stable disease or better and subjects who have disease that is not progressing at the end of 6 cycles may continue to receive volociximab alone until disease progression. Carboplatin is administered via IV infusion and dosed based on the Calvert formula (with a target area AUC of 6 mg/mL/min) for up to 6 cycles (3 weeks/cycle). Paclitaxel is administered via IV infusion and dosed at 200 mg/m2 for up to 6 cycles (3 weeks/cycle). All four drugs, when given in combination, will be infused on the same day in the following sequence: volociximab, paclitaxel, carboplatin.

Study Details

The primary purpose of this study is to examine the safety of volociximab (V) in combination with a standard treatment of carboplatin (C), paclitaxel (P), and bevacizumab (B) in subjects previously untreated with chemotherapy for advanced stage (IIIB/IV) non-squamous non-small cell lung cancer (NSCLC).

Key Dates

First listed
Apr 25, 2008
Start date
Apr 30, 2008
Status verified
Apr 2012
Primary completion
Oct 31, 2008
Completion
Oct 31, 2008

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Escalating doses of volociximab at 10, 20, and 30 mg/kg with carboplatin, paclitaxel, and bevacizumab

Primary Outcome Measure

To determine the maximum tolerated dose (MTD) of volociximab given at different doses in combination with carboplatin, paclitaxel, and bevacizumab. [ Time Frame: Dose Limiting Toxicities (DLT) will be assessed during the first treatment cycle for each cohort ]

Locations (4)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 70354BethesdaMaryland20817-7847-
Site Reference ID/Investigator# 70333HersheyPennsylvania17033-0850-
Site Reference ID/Investigator# 70355GreenvilleSouth Carolina29605-
Site Reference ID/Investigator# 70353YakimaWashington98902-

Find similar trials in Bethesda, MD

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Site Reference ID/Investigator# 70354· Bethesda, MDSite Reference ID/Investigator# 70333· Hershey, PASite Reference ID/Investigator# 70355· Greenville, SCSite Reference ID/Investigator# 70353· Yakima, WA

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